Behavior Management Using Audiovisual Tools

Not Applicable

Completed

• Conditions: Disruptive Global Behavior During Previous Treatment Visits
• Interventions: Behavioral: No distraction method; Behavioral: Distraction method

• Registration Number: NCT01643915
• Lead Sponsor: Universitat Internacional de Catalunya

Brief Summary

The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

Detailed Description

Each patient required a minimum of 2 visits for restorative treatment in a mandibular quadrant and had undergone a previous restorative dental experience. All parents or guardians of the children who participated in the study were informed about the study before enrolment, and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were not present in the operating room during the treatment. The maximum time between the 2 treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the standard process of a paediatric dental visit, the child was given an explanation as to what the visit would comprise, with the aim of interrupting the treatment as little as possible. The children knew at the beginning of the first appointment (control) that they would be able to watch a movie or play a videogame during their next visit.

Study Timeline

• Study First Submitted: 2012-07-16
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Study Start: 2012-09
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-06
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Patients aged 4-9 years.
• Patients who required a minimum of 2 visits for restorative treatment.
• Patients who had previously shown disruptive behavior (Frankl Behavior Rating Scale 1 or 2) during dental restorative treatment or pulp therapy.

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Exclusion Criteria

• Patients with reduced audiovisual capabilities.
• Patients with psychological disorders.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Control group	No distraction method	Patients with conventional treatment. No distraction method during the treatment visits.
Experimental group 1	Distraction method	Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
Experimental group 2	Distraction method	Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Primary Outcome Measures

Name	Time	Method
Global behavior during the treatment	14 days

Secondary Outcome Measures

Name	Time	Method
Self-reported anxiety during the treatment	14 days
Heart rate during the treatment measures in different time points	14 days
Degree of acceptance of the distraction method by the pediatric patient	14 days
Parental perception of patients' anxiety	14 days
Pain during the treatment	14 days

Trial Locations

Locations (1)

Universitat Internacional de Catalunya; 🇪🇸 Sant Cugat del Vallès, Barcelona, Spain